Ass'n of Am. Physicians & Surgeons v. U.S. Food & Drug Admin.

• Decision Date: 09 September 2021
• Docket Number: No. 20-1784,20-1784
• Citation: 13 F.4th 531
• Parties: ASSOCIATION OF AMERICAN PHYSICIANS & SURGEONS, Plaintiff-Appellant, v. UNITED STATES FOOD AND DRUG ADMINISTRATION ; Janet Woodcock, M.D., Acting Commissioner of Food & Drugs, in her official capacity; Biomedical Advanced Research & Development Authority ; Gary L. Disbrow, PH.D., Director, Biomedical Advanced Research & Development Authority, in his official capacity; U.S. Department of Health and Human Services ; Xavier Becerra, Secretary of Health & Human Services, in his official capacity, Defendants-Appellees.
• Court: U.S. Court of Appeals — Sixth Circuit

13 F.4th 531

ASSOCIATION OF AMERICAN PHYSICIANS & SURGEONS, Plaintiff-Appellant,

v.UNITED STATES FOOD AND DRUG ADMINISTRATION ; Janet Woodcock, M.D., Acting Commissioner of Food & Drugs, in her official capacity; Biomedical Advanced Research & Development Authority ; Gary L. Disbrow, PH.D., Director, Biomedical Advanced Research & Development Authority, in his official capacity; U.S. Department of Health and Human Services ; Xavier Becerra, Secretary of Health & Human Services, in his official capacity, Defendants-Appellees.

No. 20-1784

United States Court of Appeals, Sixth Circuit.

Decided and Filed: September 9, 2021

ON BRIEF: Andrew L. Schlafly, Far Hills, New Jersey, for Appellant. Scott R. McIntosh, Lewis S. Yelin, UNITED STATES DEPARTMENT OF JUSTICE, Washington, D.C., for Appellees.

Before: SILER, THAPAR, and MURPHY, Circuit Judges.

MURPHY, J., delivered the opinion of the court in which SILER and THAPAR, JJ., joined. SILER, J. (pg. 547), delivered a separate opinion concurring in all but Part III.A.1 of the majority opinion.

MURPHY, Circuit Judge.

In Flast v. Cohen , 392 U.S. 83, 88 S.Ct. 1942, 20 L.Ed.2d 947 (1968), the Supreme Court suggested that plaintiffs broadly have "standing" to sue over actions taken by the political branches whenever the litigants are sufficiently "adverse." See id. at 100–01, 88 S.Ct. 1942. The standing at issue in this case—associational standing—grew out of the same "judicial thinking" as Flast . Nat'l Automatic Laundry & Cleaning Council v. Shultz , 443 F.2d 689, 693 (D.C. Cir. 1971). It permits an association that has suffered no injury to sue on behalf of members who have. Yet the Court has since criticized Flast for overlooking that standing (and, in particular, its requirement that a plaintiff identify a personal injury) represents a key part of the Constitution's separation of powers. Lewis v. Casey , 518 U.S. 343, 353 n.3, 116 S.Ct. 2174, 135 L.Ed.2d 606 (1996). It is not clear how associational standing comports with this more recent guidance. At the least, the guidance should lead us to vigilantly ensure that an association's members have incurred a personal injury. And here, the plaintiff (an association of physicians) failed to plausibly plead that any member has been injured by the actions of the Food and Drug Administration (FDA) that it criticizes. We thus affirm the dismissal of its complaint.

I

Under the Federal Food, Drug, and Cosmetic Act, a drug manufacturer cannot distribute a drug in interstate commerce without obtaining the FDA's approval for the uses listed on the drug's official label. See 21 U.S.C. § 355(a). To obtain FDA approval, a manufacturer generally must conduct clinical trials establishing that the drug is safe and effective for those intended uses. See id. § 355(d). In emergency situations, however, the FDA may allow the distribution of an unapproved drug or of an approved drug for an unapproved use. See id. § 360bbb-3(a)(1)–(2).

Although the Act regulates a manufacturer's distribution of drugs, it does not go further by regulating a doctor's practice of medicine. See Buckman Co. v. Plaintiffs’ Legal Comm. , 531 U.S. 341, 350–51, 121 S.Ct. 1012, 148 L.Ed.2d 854 (2001). The Act thus does not prohibit doctors from prescribing an FDA-approved drug (say, a chemotherapy drug approved to treat leukemia

) for an "off-label" use (say, treatment of other cancers ). See

United States v. Caronia , 703 F.3d 149, 153 (2d Cir. 2012). It instead leaves the regulation of doctors to the states. Cf. Dent v. West Virginia , 129 U.S. 114, 121–24, 9 S.Ct. 231, 32 L.Ed. 623 (1889).

This case involves "hydroxychloroquine

." The FDA approved this drug for distribution in 1955. It has now approved the drug to treat malaria, lupus, and arthritis. A CDC fact sheet describes the drug as "relatively well tolerated" and lists its most common side effects as "stomach pain, nausea, vomiting, and headache." Fact Sheet, R.8-14, PageID 286. Still, a patient may not use hydroxychloroquine unless a doctor prescribes it.

The FDA has not approved hydroxychloroquine

to treat COVID-19. Early in the pandemic, the FDA relied on the then-available data to conclude that the drug might help treat the disease. In March 2020, the agency issued an Emergency Use Authorization ("Authorization") under § 360bbb-3(a). The Authorization permitted the hydroxychloroquine in the federal government's strategic national stockpile to be distributed for treatment of COVID-19 patients. Yet it granted access to this large stockpile only in limited circumstances. The Authorization stated that the drug "may only be used to treat adult and adolescent patients who weigh 50 kg or more hospitalized with COVID-19 for whom a clinical trial is not available, or participation is not feasible." Auth., R.8-8, PageID 262.

The Association of American Physicians & Surgeons, a nonprofit organization with physician members, believed that the Authorization did not offer broad enough access to the federal stockpile. It sued the FDA and its Commissioner, the Biomedical Advanced Research and Development Authority and its Director, and the Department of Health and Human Services and its Secretary. (For simplicity, we will refer to all defendants as the FDA.) The Association alleged that hydroxychloroquine can help patients if taken as a prophylaxis before they get COVID-19 or as an initial treatment after such a diagnosis. It thus sought declaratory and injunctive relief against the Authorization's restrictions barring use of hydroxychloroquine

to treat COVID-19 except for hospitalized patients.

The Association pleaded three claims. It alleged that these restrictions violated the implied equal-protection guarantee in the Fifth Amendment's Due Process Clause. Compl., R.1, PageID 17, 20–22. It alleged that the restrictions violated the First Amendment right to associate by limiting access to medication useful for meeting in groups during a pandemic. Id. , PageID 22–23. And it alleged that the restrictions violated the Administrative Procedure Act. Id. , PageID 22.

The Association also pleaded three injuries. It alleged an injury to itself: The Association was considering canceling a conference purportedly due to the Authorization's restrictions. Id. , PageID 23. It next invoked associational standing on behalf of its physician members: It claimed that the members could not prescribe hydroxychloroquine for COVID-19 because of the restrictions. Id. , PageID 19. The Association lastly invoked third-party standing: It alleged that its members’ patients could not obtain the drug for the treatment of COVID-19. Id.

The district court held that none of these injuries plausibly pleaded the Association's standing to challenge the Authorization. The court dismissed the complaint for lack of subject-matter jurisdiction under Federal Rule of Civil Procedure 12(b)(1). See Ass'n of Am. Physicians & Surgeons v. FDA , 479 F. Supp. 3d 570, 579–85 (W.D. Mich. 2020). We review this decision de novo. See CHKRS, LLC v. City of Dublin , 984 F.3d 483, 488 (6th Cir. 2021).

Before doing so, we flag a mootness issue. The Authorization had a short shelf life. Within months, the FDA had rescinded it because additional data suggested that hydroxychloroquine was ineffective at treating COVID-19. 85 Fed. Reg. 56,231, 56,232 (Sept. 11, 2020). Must we ensure that these new facts do not moot the Association's suit before addressing its standing? No, the Supreme Court has told us that we have discretion to choose between non-merits grounds for dismissing a suit. See Sinochem Int'l Co. v. Malaysia Int'l Shipping Corp. , 549 U.S. 422, 431, 127 S.Ct. 1184, 167 L.Ed.2d 15 (2007). We thus exercise our discretion to begin with standing, which, as it turns out, moots any mootness issue. See In re 2016 Primary Election , 836 F.3d 584, 587 (6th Cir. 2016).

II

The Association spends much of this appeal attacking the FDA's actions on their policy and legal merits. It says that it should have standing because the FDA has engaged in "anti-life conduct" that has contributed to the "deaths of many thousands of innocent Americans." Appellant's Br. 28–29. It adds that it should have standing because the FDA has committed "wrongdoing" by making "false and misleading" claims about hydroxychloroquine. Id. at 33, 41. These merits arguments misunderstand standing's basic function, so we start with first principles.

The Constitution separates the general powers of government: Article I vests "legislative Powers" in the Congress; Article II vests the "executive Power" in the President; and Article III vests the "judicial Power" in the Supreme Court and inferior courts. By doing so, the Constitution at once both protects and restrains the judiciary. It protects the courts from efforts by the political branches to interfere with their duty to resolve disputes between litigants. The legislative branch, for example, cannot reverse a court's final judgment. Plaut v. Spendthrift Farm, Inc. , 514 U.S. 211, 225–26, 115 S.Ct. 1447, 131 L.Ed.2d 328 (1995). And the executive branch cannot render a final judgment in a case of the type traditionally resolved by courts. Stern v. Marshall , 564 U.S. 462, 484, 131 S.Ct. 2594, 180 L.Ed.2d 475 (2011).

Yet this separation of powers also protects the political branches from the courts. Courts have a specific power: to decide "Cases" or "Controversies" between litigants. U.S. Const. art. III, § 2. They do not have a standalone power to evaluate the constitutionality of every law passed by Congress or every initiative implemented by the President. See Ariz. Christian Sch. Tuition Org. v. Winn , 563 U.S. 125, 146, 131 S.Ct. 1436, 179 L.Ed.2d 523 (2011). A court may engage in such judicial review and issue a remedy regulating the political branches only "when necessary in the execution of" its duty to decide a case. Summers v. Earth Island Inst. , 555 U.S. 488, 492, 129 S.Ct. 1142, 173 L.Ed.2d 1 (2009). It may not issue an advisory interpretation of the...